Topical Report Submittal Procedure
A licensee or industry organization may, on its own initiative or at the request of the U.S. Nuclear Regulatory Commission (NRC), submit a topical report regarding a technical topic related to nuclear power plant (NPP) safety for NRC review and approval. The NRC staff will review such reports independently of any NPP construction permit or operating license review. Any industry organization that plans to submit a report to the NRC for review as part of the Topical Report program should adhere to the procedures discussed in Office Instruction LIC-500, and summarized throughout this page:
- Communication and Correspondence
- Copy Requests
- Review Fees
- Proper Formatting
- Publication of Approved Topical Reports
- Revision of Approved Topical Reports
- Withdrawal of Approved Topical Reports
Communication and Correspondence
Interested parties should consult the NRC's cognizant Vendor/Owners Group Project Manager well in advance of submitting a topical report to ensure that the proposed report meets the Criteria for a Topical Report or one of the Exceptions to the Criteria, and to clarify the NRC's requirements for preparing and submitting the report. In addition, an applicant should request a pre-application meeting with the NRC staff to discuss the proposed topical report before submitting an application, unless the NRC staff agrees that a pre-application meeting is not needed.
If the NRC staff determines that the proposed topical report qualifies for review, the applicant submits an official letter requesting NRC review and approval along with a copy of the proposed topical report. The first paragraph of the official topical report application letter should specify whether the topical report is believed to contain proprietary information, and also list the Topical Report Identifier, title, and issue date. In addition, the letter should state the date when approval of the report is expected to be needed for an application.
The application letter and enclosures should be addressed to the Document Control Desk, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; however, if requesting an exemption to the established fees, the applicant should follow the address requirements under Review Fees. The preferred submission method for most topical reports is electronically through the Electronic Information Exchange (EIE), but a hard copy (paper or CD-ROM) enclosure with the application letter is also acceptable. See Electronic Submittals and Copy Requests for more information on each type of submission.
A topical report may contain proprietary information that can be withheld from public disclosure as allowed by 10 CFR 2.390. In this case, a non-proprietary version of the topical report should be submitted alongside the complete proprietary version. If the NRC verifies that the proprietary version meets the conditions of 10 CFR 2.390, only the non-proprietary version of the topical report will be disclosed to the public.
The NRC will determine whether the submitted topical report should be accepted for review, and if so, assign a prioritization value to it. The NRC will usually advise the submitting organization of the outcomes of both of these decisions within 60 days of receipt of the topical report submission. More information on prioritization assignments can be found in Office Instruction LIC-500, Enclosure 2.
When submitting a topical report to the NRC in hard copy, submit the following quantities, plus any additional copies that the NRC staff requests. These quantities apply to initial submittals, revisions, supplements, and NRC-approved versions.
|Type of Report||Number of Copies of Report and Cover Letter|
|Nonproprietary||1 original to the Document Control Desk*
3 copies to the cognizant Vendor/Owners Group Project Manager under separate cover
|Proprietary||1 original to the Document Control Desk*
3 copies to the cognizant Vendor/Owners Group Project Manager under separate cover
|Proprietary and nonproprietary versions||1 original of each version to the Document Control Desk*
3 copies of the proprietary version and 1 copy of the nonproprietary version to the cognizant Vendor/Owners Group Project Manager under separate cover
*If a fee exemption is requested, follow the address requirements under Review Fees.
Submissions of topical report reviews are normally subject to fees based on the full cost of the review, as set forth in Title 10, Part 170, of the Code of Federal Regulations (10 CFR Part 170), "Fees for Facilities, Materials, Import and Export Licenses, and Other Regulatory Services Under the Atomic Energy Act of 1954, As Amended." Exemptions to the fee recovery requirements are made on a case-by-case basis, as set forth in 10 CFR 170.11.
If a topical report is submitted in response to certain NRC generic letters or bulletins, in response to an NRC request (at the Division Director level or above), or as a means of exchanging information between the industry and the NRC for the purpose of supporting the NRC's generic regulatory improvement program, the report may qualify for a review fee exemption. Review of the topical report must assist the staff in developing the NRC's generic regulatory improvement program and not merely be a first-of-its-kind review that may benefit others that follow.
A fee exemption does not mean that the NRC does not charge for the review; it only means that the fee will not be assessed solely to the organization that requested the review. When an exemption is granted, the cost of the review is paid by appropriate licensees under 10 CFR Part 171, "Annual Fees for Reactor Licenses and Fuel Cycle Licenses and Materials Licenses, Including Holders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed by the NRC." The NRC has been directed by Congress to keep these fees as low as possible. If a fee exemption is requested, the NRC does not begin its review until it decides whether to grant the exemption, unless the submitting organization has agreed to pay the fee in case the exemption is denied.
Topical reports that contain fee exemption requests should be addressed to the Chief Financial Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
Proper formatting of topical reports involves the following considerations, as discussed on this page:
Topical Report Identifier
Each submitting organization assigns a unique alphanumeric identifier to each topical report for filing and reference purposes, and places it in the upper right-hand corner of the first page or cover page of all documents related to the report. Consult the NRC's cognizant Vendor/Owners Group Project Manager to ensure that the selected identifier does not conflict with that of another organization. In general, however, the following guidance applies:
- For all proprietary reports, place "-P" or "(P)" at the end of the identifier.
- For the corresponding nonproprietary report, place "-NP" or "(NP)" at the end of the identifier, rather than "-P" or "(P)".
- For all NRC-approved proprietary reports, place "-P-A" or "(P-A)" after the identifier, where the A indicates NRC approval.
The submitting organization should identify all responses to the NRC's comments or requests for additional information using both the NRC TAC number and the submitting organization's identifier for the given topical report, followed by "Response to Comment," "Response to Request for Additional Information by the NRC Staff," or (if appropriate) "Response by Appendix or Supplement to the Original Topical Report." The NRC discourages the use of an addendum. Although a revision to the original topical report can constitute a response, the NRC closes out the old review and initiates a new review for each revision submitted.
Topical report submissions should include an abstract (no longer than one page) that summarizes the contents of the report and the conclusions reached.
Handling of Proprietary information
Italics, marginal lines, underscoring, or bracketing are used to identify all material that is considered to be proprietary information.
The applicant indicates in the nonproprietary version what information has been deleted from the proprietary version because the submitting organization considers it to be proprietary. For example, if brackets are used in the proprietary version to show what portion of the information is considered proprietary, the nonproprietary version should leave blank the portion between the brackets to show that information was removed. Upon submitting a properly marked topical report (see 10 CFR 2.390, "Public inspections, exemptions, requests for withholding") that is considered proprietary and a justification for why it is proprietary, the NRC staff determines whether the information should be withheld from public disclosure according to 10 CFR 2.390 and notifies the submitting organization of its determination.
Publication of Approved Topical Reports
The NRC will complete a safety evaluation of the topical report and return it to the sponsoring organization, possibly with additional conditions or requirements to be included in the topical report. The sponsoring organization should submit a final revision of the topical report with an approved ("-A") designation that includes these changes. The NRC staff will conduct a final verification of the "–A" revision for completeness and accuracy of the entire topical report. At the successful conclusion of this verification, the NRC will issue a letter to the applicant approving the "-A" topical report for referencing in licensing actions, and add it to the NRC's library of approved topical reports. For access to currently approved, non-proprietary topical report publications, see the Public Availability section of the Overview page.
The sponsoring organization's submission of the "-A" topical report for final review should include the NRC's transmittal letter, safety evaluation, and all requests for additional information and the related responses immediately after the title page. For a proprietary topical report, both proprietary and non-proprietary versions must be published and submitted to the NRC.
Revision of Approved Topical Reports
If an NRC-approved topical report needs to be revised, but is not obsolete, the applicant submits the revision to the NRC, following the same procedures used to submit a topical report for the first time, with the following exceptions:
- State in a note on the cover page of the revision that it supersedes and replaces all previous versions of the report.
- Place the same identifier on the revision used on the original version followed by the revision number (e.g., Revision 1 or Revision 2).
- Do not include "-A" or "(A)", indicating an approved report, as part of the identifier on the revision.
Withdrawal of Approved Topical Reports
Over time, a topical report may become obsolete because it no longer adequately addresses the current state of technology, or the NRC's criteria or regulations have changed so that it is no longer applicable, or for other reasons. To withdraw an approved topical report, the applicant submits a letter requesting that NRC withdraw the report. If the NRC categorizes the report "withdrawn," it can no longer be referenced in a license application. However, the report may be replaced by an updated or new topical report, which has a new identifier and new NRC TAC number to avoid confusion with the withdrawn report.